In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Patients with de novo lesions in native coronary arteries that meet the eligibility criteria and
sign the informed consent form will participate in this study.
The observed event rate for the primary endpoints is assumed to be 2% at 12
months so a sample size of 200 subjects will provide a 95% confidence interval [0.5%, 5%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of 230 patients will be conservatively enrolled in this trial to ensure that at least 200 patients will be evaluable at 12 months.
Centers (n≈30) are allowed to enroll a maximum of 40 subjects per center or until study enrollment has been completed, whichever comes first.
Primary Endpoint The primary endpoint for all patients enrolled in this study is the composite rate
of cardiac death and TV MI at 12 months
Secondary Endpoints Composite endpoints (hospital discharge, 30 days, 6 months, 12 months, and 24 months post-procedure): - Major Adverse Cardiac Events (MACE) - Target Lesion Failure (TLF) - Target Vessel Failure (TVF) - Cardiac Death and TV MI
In addition, the following will be assessed: - Procedural success - Device success - Lesion success
Followup Visits and Length of Followup
The length of follow-up is 2 years. Frequency of Follow-up Assessments: 30 days, 6 months,
12 months, and 24 months post-procedure.
The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 12 months. The study will be conducted for a minimum of two (2) years from enrollment of the final subject.